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A Study to Investigate the Effect of AZD6234 and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity

NCT ID: NCT07013643

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-04

Study Completion Date

2026-07-20

Brief Summary

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This study will measure the effects of multiple doses of AZD6234 and a combination of AZD6234 and AZD9550 given as injection(s) on pharmacokinetics (PK) of combined oral contraceptive ethinyl estradiol (EE)/levonorgestrel (LEVO) in healthy female participants with obesity.

Detailed Description

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This is a Phase I, open-label, single-sequence, multiple-cohort study which will be performed at multiple study sites in healthy females of childbearing and non-childbearing potential.

The purpose of this study is to investigate the effect of AZD6234 and a combination of AZD6234 and AZD9550 on the PK, safety and tolerability of a combined oral contraceptive, ethinyl estradiol/levonorgestrel (EE/LEVO).

The study will have 2 cohorts, and each cohort will consist of 5 periods which include, Screening, Start, Up-titration, Maintenance, and Follow-up periods.

Conditions

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Healthy Participants

Keywords

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Obesity Overweight Oral contraceptives Pharmacokinetics Drug Interaction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort-1 AZD6234 + EE/LEVO + Acetaminophen (APAP)

Participants will receive combined oral contraceptive (EE/LEVO) and, separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 administration.

Group Type EXPERIMENTAL

AZD6234

Intervention Type DRUG

AZD6234 will be administered as a subcutaneous injection in the abdomen.

Ethinyl estradiol/Levonorgestrel (EE/LEVO)

Intervention Type DRUG

EE/LEVO will be administered as combined oral tablets.

Acetaminophen (APAP)

Intervention Type DRUG

APAP will be administered orally as a solution.

Cohort-2: AZD6234+AZD9550+EE/LEVO+APAP

All participants will receive combined oral contraceptive EE/LEVO and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous administered AZD6234 and AZD9550.

Group Type EXPERIMENTAL

AZD6234

Intervention Type DRUG

AZD6234 will be administered as a subcutaneous injection in the abdomen.

Ethinyl estradiol/Levonorgestrel (EE/LEVO)

Intervention Type DRUG

EE/LEVO will be administered as combined oral tablets.

Acetaminophen (APAP)

Intervention Type DRUG

APAP will be administered orally as a solution.

AZD9550

Intervention Type DRUG

AZD9550 will be administered as a subcutaneous injection in the abdomen.

Interventions

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AZD6234

AZD6234 will be administered as a subcutaneous injection in the abdomen.

Intervention Type DRUG

Ethinyl estradiol/Levonorgestrel (EE/LEVO)

EE/LEVO will be administered as combined oral tablets.

Intervention Type DRUG

Acetaminophen (APAP)

APAP will be administered orally as a solution.

Intervention Type DRUG

AZD9550

AZD9550 will be administered as a subcutaneous injection in the abdomen.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All participants must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
* Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.

o Hormonal contraceptives and estrogen-containing hormonal methods of birth control are not permitted due to potential effect and influence on the results using a combined oral contraceptive assessment.
* Females of non-childbearing potential must be confirmed at the Screening Visit.
* Have a Body Mass Index (BMI) ≥ 25 kg/m2 inclusive and weigh at least 60 kg.

Exclusion Criteria

* History of any clinically important disease or disorder (gastroparesis, deep vein thrombosis, venous thromboembolism, previous surgery of the upper gastrointestinal tract, cardiovascular disease, neuromuscular or neurogenic disease, severe vitamin D deficiency, type I or type II diabetes mellitus, glycated hemoglobin (HbA1c) ≥ 6.5% at screening, history of neoplastic disease, basal calcitonin level \>50 ng/L (50 pg/L) at screening (Cohort 2), history of acute or chronic pancreatitis or pancreatic amylase or lipase \>2×ULN at screening (cohort 2), prior history of cholecystectomy or untreated cholelithiasis and personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia type 2 (MEN2) (cohort 2)).
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically important illness, medical/surgical procedure, or trauma.
* Any laboratory values with deviations or clinically important abnormalities in clinical chemistry, hematology, or urinalysis.
* Any positive result on screening for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) or Human immunodeficiency virus (HIV).
* Abnormal vital signs.
* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead electrocardiogram (ECG), at screening.
* Current smokers or those who have smoked or used nicotine products.
* Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
* Statin treatment within 4 weeks prior to the start of study treatment.
* Current use of estrogen-containing products.
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Glendale, California, United States

Site Status RECRUITING

Research Site

Brooklyn, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

Phone: 1-877-240-9479

Email: [email protected]

Other Identifiers

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D8750C00006

Identifier Type: -

Identifier Source: org_study_id